MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TAPERED SPACER ARTICUL/EZE -3 HIP FEMORAL SPACER

Catalog Number 136308000

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address pain. Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

This product was reported in error. No patient death, serious injury or evidence of reportable product malfunction occurred. Depuy considers the investigation closed at this time. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: TAPERED SPACER ARTICUL/EZE -3
• Type of Device: HIP FEMORAL SPACER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7104937
• Report Number: 1818910-2017-51228
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032663
• UDI-Public: 10603295032663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 136308000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 85 YR
• Patient Outcome(s): Required Intervention